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Background  Chromogenic in situ hybridization (CISH) is fast becoming a well established technique for easy and sensitive determination of HER2 gene status in breast cancer. However, for the chromogenic method to achieve status as a safe and reliable technique, the method needs to be validated against already known and validated FISH techniques.    Methods  Here it is reported from a comparative study where HER2 gene status obtained by  HER2  CISH pharmDx™ Kit was compared to HER2 gene status obtained by the FDA approved  HER2  FISH pharmDx™ Kit and the PathVysion HER-2 DNA probe Kit. The study included 365 formalin fixed and paraffin-embedded invasive breast cancer tissue specimens collected consecutively at a US reference laboratory.    Results  The data obtained revealed an overall HER2 status concordance of approximately 98% for comparisons of  HER2  CISH pharmDx™ Kit to both  HER2  FISH pharmDx™ Kit and PathVysion HER-2 DNA Probe Kit.    Conclusions  The concordance between results obtained using the recently FDA approved  HER2  CISH pharmDx™ Kit with previously FDA approved FISH techniques for HER2 gene status determination indicate that the  HER2  CISH pharmDx™ Kit is a reliable chromogenic alternative to fluorescence-based methods.

bmc clinical pathology

Dual color chromogenic in situ hybridization for determination of HER2 status in breast cancer: a large comparative study to current state of the art fluorescence in situ hybridization